
Key Takeaways From Regency Centers Analyst Ratings
WASHINGTON — U.S. Sen. Joe Manchin bucked his party in 2021 when he refused to support a $1.8 trillion bill on taxes, social programs and clean energy, thus dooming President Joe Biden's "Build Back Better" initiative. Then this month, in one of his final actions as a member of Congress, he also bucked his party and voted against a nominee that would have continued the Democratic majority on the National Labor Relations Board once both he and Biden leave office. In between, Manchin played outsized roles in Biden's economic stimulus program and his infrastructure bill, as well as the smaller climate change and health care law that came out of the wreckage of Build Back Better. In exit interviews, Manchin, I-W.Va., said his former party had gone too far to the left and left him in a position he did not want — the one individual who could make or break legislation. "I did not run for that position," Manchin told the Washington Post. "I did not try to wedge myself in that and be the deciding vote." He said he made it clear once the Democrats won the trifecta of the White House, Senate and House in 2021 that he was not going to be a guaranteed "yes" vote. "I don't work for you," he said he told his colleagues, according to the Post interview. "You didn't hire me and you can't fire me. I work for the people of West Virginia on behalf of the United States government. That's who I have to answer to, and if this stuff doesn't make sense no matter how bad you want it, I can't vote for it." None of Biden's major accomplishments — the economic stimulus package, the infrastructure law, the climate change and health care measure, and the funding to bring manufacturing, including those of computer chips, back to the U.S. — would have passed without Manchin's vote. "Each of these victories required senators to come together from both sides of the aisle to find solutions for Americans," he said on the Senate floor earlier this month in his farewell speech. "These were bills that just made common sense. And when each side could take just a little step to find common ground, powerful things have happened." In his closing weeks as a senator, he touted funding in those bills for clean energy manufacturing in West Virginia coal communities, for a new hanger at a small West Virginia airport and for a carbon storage hub in the state. He singled out the Appalachian Regional Clean Hydrogen Hub (Arch2), which will receive up to $925 million in federal funding for projects in West Virginia, Pennsylvania, Ohio and Kentucky. "You can't eliminate your way to a cleaner environment, you can innovate it," Manchin said in his floor speech. "That's why we funded the development of regional hydrogen hubs and made sure one of them would be in the Appalachia region." His closing words on the Senate floor also talked about the need for lawmakers to work together, and his support for the filibuster that requires 60 votes — support from both parties — to pass legislation. But it didn't always work, he said. Popular legislation such as overhauling immigration laws and expanding background checks for guns failed, he said. "These opportunities were missed because we've let politics get in the way of doing our job," he said in his floor speech. "I am not saying that dealing with politics is easy. It's not. It's messy. I've had my share of tough votes. At times, I have felt like the whole Senate was united — in being upset with me. So sometimes I guess we did come together." Harsh words for Democrats Manchin officially left the Democratic Party in May and registered as an independent. He continued to caucus with his fellow Democrats until the end. But he's leaving office with some harsh words for the party he left behind. After all, he said, he wasn't the only person who left the Democratic Party. "The brand got so bad. The 'D' brand has been so maligned from the standpoint of — it's just — it's toxic," he said in the CNN interview. He said Democrats have been telling people what they have to believe in and what they have to do, no matter how outrageous. "The Democrat I grew up being, they wanted to make sure that people had an opportunity for a good job, a good pay," he told CNN. "I will protect you. Just don't try to mainstream it. And the Democratic Party, the Washington Democrats, have tried to mainstream the extreme. ...They have — they have basically, expanded upon thinking, well, we want to protect you there, but we're going to tell you how you should live your life." He never endorsed Vice President Kamala Harris for president in 2024, and said the election results showed that Americans didn't want someone on the left. He said it was "nuts" and "completely insane" to say Harris lost because she wasn't progressive enough. The problem was that her liberal voting record made it hard for her to pivot to the center in the fall campaign, he said, "They're saying if Kamala would have been who she always has been, pretty far to the left, it would have been better for her. That's crazy," Manchin told CNN. "Basically, she was having a hard time trying to come back to the middle and then speak about it with any conviction. If you try to be somebody you're not, it's hard." Manchin resisted entreaties that he run for president as an independent in 2024, lest he be a spoiler. But he said there was room for a real third party. "The centrist part of both parties," he said on CNN. "So the centrist moderate vote decides who's going to be the president of the United States. And when they get here, they don't govern that way. Neither side does. They go to their respective corners. So if a centrist had a voice and had a party that could make both of these, the Democrat and Republican Party come back, OK, that would be something." Manchin told CNN that the new organization would be called the American Party, and while he wouldn't lead it, "I'll be the best cheerleader they've ever had." (c)2024 the Pittsburgh Post-Gazette. Visit the Pittsburgh Post-Gazette at www.post-gazette.com . Distributed by Tribune Content Agency, LLC.
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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec 8, 2024-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from a five-year follow-up of the pivotal Phase III POLARIX study evaluating Polivy ® (polatuzumab vedotin-piiq) in combination with Rituxan ® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lymphoma (DLBCL). Data were presented in an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, December 7-10, 2024 in San Diego, California. This latest analysis conducted after a median follow-up of 60.9 months, includes descriptive data on primary and secondary endpoints, as well as safety results. “POLARIX was the first trial to elevate treatment standards for frontline diffuse large B-cell lymphoma in 20 years and we are additionally encouraged by the five-year follow-up results,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “More than 38,000 people worldwide have been treated with Polivy in combination with R-CHP and these data continue to underscore its potential to improve outcomes for people diagnosed with this aggressive lymphoma.” Follow-up exploratory analysis after five-years indicated a positive trend in overall survival (OS) in the intent-to-treat (ITT) population in favor of Polivy in combination with R-CHP compared to Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). Results showed a trend in reduction in the risk of death (HR 0.85; 95% CI: 0.63–1.15) for people with previously untreated DLBCL with the Polivy combination, an improvement on the three-year follow-up data (HR 0.94; 95% CI: 0.67–1.33). The five-year analysis of POLARIX indicates that the full difference in OS between treatment arms has yet to be observed and an additional two years of follow-up will continue. “Diffuse large B-cell lymphoma is a notoriously challenging cancer to treat, however, Polivy in combination with R-CHP has shown to be a critical advance for patients by helping to reduce relapse and disease progression,” said Gilles Salles, M.D., Ph.D., chief of Lymphoma Service, Division of Hematological Malignancies, Memorial Sloan Kettering Cancer Center, New York. “The survival trend seen in this follow-up analysis reinforces the potential impact of frontline treatment with Polivy in combination with R-CHP and its role as a standard of care therapy.” In addition to the positive trend in OS, an observational analysis suggested nearly 25% fewer follow-up treatments such as radiation, systemic chemotherapy and CAR-T cell therapy were needed in patients receiving Polivy in combination with R-CHP compared to those treated with R-CHOP (38.3% versus 61.7%). At five years of follow-up, benefits in progression-free survival and disease-free survival with Polivy in combination with R-CHP were maintained, consistent with the three-year follow-up data, reinforcing the potential of Polivy in combination with R-CHP to provide durable and lasting remissions. The latest follow-up data also showed a numerical reduction in death related to patients’ lymphoma in those treated with Polivy in combination with R-CHP compared to those treated with R-CHOP (9.0% versus 11.4%). The safety profile remains consistent with the known profiles of the individual study medicines with no new safety signals observed, reinforcing the positive benefit-risk profile of this Polivy combination. Results from an expanded cohort of 1,000 patients including global and Chinese patients demonstrated comparability to the global ITT population. Polivy in combination with R-CHP is currently approved for the treatment of first-line (1L) DLBCL in more than 90 countries worldwide including the U.S., countries throughout the EU, the U.K., Japan, Canada and China. Genentech continues to work with health authorities around the world to bring this treatment regimen to even more patients. Genentech aims to offer various treatment options for DLBCL that meet the diverse needs of patients and healthcare systems. In an effort to elevate treatment standards even further, Genentech is exploring Polivy in combination with other molecules, including its bispecific antibodies. Studies include the Phase III SUNMO trial evaluating the efficacy and safety of subcutaneously administered Lunsumio ® (mosunetuzumab-axgb) in combination with intravenous (IV) Polivy versus IV Rituxan plus gemcitabine and oxaliplatin (R-GemOx) in second-line or later DLBCL, and the Phase III SKYGLO trial investigating the efficacy of Polivy in combination with R-CHP and Columvi ® (glofitamab-gxbm) versus Polivy in combination with R-CHP in 1L DLBCL. About the POLARIX Study POLARIX [ NCT03274492 ] is an international Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy ® (polatuzumab vedotin-piiq) plus Rituxan ® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) versus Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Eight-hundred and seventy-nine patients were randomized 1:1 to receive either Polivy plus R-CHP plus a vincristine placebo for six cycles, followed by Rituxan for two cycles; or R-CHOP plus a Polivy placebo for six cycles, followed by two cycles of Rituxan. The primary outcome measure is progression-free survival as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma. POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). About Diffuse Large B-Cell Lymphoma Diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and is the most common form of non-Hodgkin’s lymphoma (NHL) in the U.S. While many people with DLBCL are responsive to treatment, the majority of those who relapse or are refractory to subsequent treatments have poor outcomes. DLBCL not otherwise specified is the most common category of large B-cell lymphoma (LBCL) and accounts for about 80% or more of cases. It applies to cases that do not fall into any specific disease subgroups of LBCL. About Polivy ® (polatuzumab vedotin-piiq) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL. Polivy U.S. Indication Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL). Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies. Important Safety Information Possible serious side effects Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects. Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication Side effects seen most often The most common side effects during treatment were Nerve problems in arms and legs Nausea Tiredness or lack of energy Diarrhea Constipation Hair loss Redness and sores of the lining of the mouth, lips, throat, and digestive tract Polivy may lower your red or white blood cell counts and increase uric acid levels. Polivy may not be for everyone. Talk to your doctor if you are Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment. You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . You may also report side effects to Genentech at (888) 835-2555. Please see the full Prescribing Information and visit https://www.Polivy.com for additional Important Safety Information. About Lunsumio ® (mosunetuzumab-axgb) Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin’s lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers. Lunsumio U.S. Indication Lunsumio (mosunetuzumab-axgb) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer. It is not known if Lunsumio is safe and effective in children. The conditional approval of Lunsumio is based on response rate. There are ongoing studies to establish how well the drug works. What is the most important information I should know about Lunsumio? Lunsumio may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Lunsumio and can also be severe or life-threatening. Get medical help right away if you develop any signs or symptoms of CRS at any time, including: fever of 100.4°F (38°C) or higher chills low blood pressure fast or irregular heartbeat tiredness or weakness difficulty breathing headache confusion feeling anxious dizziness or light-headedness nausea vomiting Due to the risk of CRS, you will receive Lunsumio on a “step-up dosing schedule.” The step-up dosing schedule is when you receive smaller “step-up” doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment You will receive a higher dose of Lunsumio on Day 15 of your first cycle of treatment If your dose of Lunsumio is delayed for any reason, you may need to repeat the step-up dosing schedule Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS Your healthcare provider will check you for CRS during treatment with Lunsumio and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Lunsumio, if you have severe side effects. What are the possible side effects of Lunsumio? Lunsumio may cause serious side effects, including: neurologic problems. Lunsumio can cause serious and life-threatening neurological problems. Your healthcare provider will check you for neurologic problems during treatment with Lunsumio. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with Lunsumio, including: headache numbness and tingling of the arms, legs, hands, or feet dizziness confusion and disorientation difficulty paying attention or understanding things forgetting things or forgetting who or where you are trouble speaking, reading, or writing sleepiness or trouble sleeping tremors loss of consciousness seizures muscle problems or muscle weakness loss of balance or trouble walking tiredness serious infections. Lunsumio can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with Lunsumio, including: fever of 100.4° F (38° C) or higher chest pain tiredness shortness of breath painful rash sore throat pain during urination feeling weak or generally unwell hemophagocytic lymphohistiocytosis (HLH) . Lunsumio can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with Lunsumio. Your health care provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include: fever enlarged spleen easy bruising low blood cell counts liver problems low blood cell counts. Low blood cell counts are common during treatment with Lunsumio and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with Lunsumio. Lunsumio can cause the following low blood cell counts: low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems growth in your tumor or worsening of tumor related problems (tumor flare). Lunsumio can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with Lunsumio: chest pain cough trouble breathing tender or swollen lymph nodes pain or swelling at the site of the tumor Your healthcare provider may temporarily stop or permanently stop treatment with Lunsumio if you develop severe side effects. The most common side effects of Lunsumio include: tiredness, rash, fever, and headache. The most common severe abnormal blood test results with Lunsumio include: decreased phosphate, increased glucose, and increased uric acid levels. Before receiving Lunsumio, tell your healthcare provider about all of your medical conditions, including if you: have ever had an infusion reaction after receiving Lunsumio have an infection, or have had an infection in the past which lasted a long time or keeps coming back have or have had Epstein-Barr Virus are pregnant or plan to become pregnant. Lunsumio may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lunsumio Females who are able to become pregnant: your healthcare provider should do a pregnancy test before you start treatment with Lunsumio you should use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of Lunsumio are breastfeeding or plan to breastfeed. It is not known if Lunsumio passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of Lunsumio Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while receiving Lunsumio? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems. These are not all the possible side effects of Lunsumio. Talk to your healthcare provider for more information about the benefits and risks of Lunsumio. You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . You may also report side effects to Genentech at (888) 835-2555. Please see Important Safety Information, including Serious Side Effects, as well as the Lunsumio full Prescribing Information and Medication Guide or visit https://www.Lunsumio.com . About Columvi ® (glofitamab-gxbm) Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Genentech’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development program that also includes Lunsumio ® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Genentech is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma. Columvi U.S. Indication Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer. It is not known if Columvi is safe and effective in children. The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works. What is the most important information I should know about Columvi? Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death. Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including: fever of 100.4°F (38°C) or higher chills or shaking fast or irregular heartbeat dizziness or light-headedness trouble breathing shortness of breath Due to the risk of CRS, you will receive Columvi on a “step-up dosing schedule”. A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1). You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller “step-up” doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose. You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2). If your dose of Columvi is delayed for any reason, you may need to repeat the “step-up dosing schedule”. If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi. Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions. Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects. Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away. What are the possible side effects of Columvi? Columvi may cause serious side effects, including: Cytokine Release Syndrome. Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including: headache confusion and disorientation difficulty paying attention or understanding things trouble speaking sleepiness memory problems numbness, tingling, or weakness of the hands or feet dizziness shaking (tremors) Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat. Growth in your tumor or worsening of tumor related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare: tender or swollen lymph nodes pain or swelling at the site of the tumor chest pain cough trouble breathing The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness. The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting). Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects. Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you: have an infection have kidney problems are pregnant or plan to become pregnant. Columvi may harm your unborn baby Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with Columvi. You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi. are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while receiving Columvi? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems. These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi. You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . You may also report side effects to Genentech at (888) 835-2555. Please see Important Safety Information, including Serious Side Effects , as well as the Columvi full Prescribing Information and Medication Guide or visit https://www.Columvi.com About Genentech in Hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology . About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com . Dr. Salles has financial interests related to Roche and Genentech. View source version on businesswire.com : https://www.businesswire.com/news/home/20241208818007/en/ CONTACT: Media Contact: Kristen Ingram, (650) 467-6800Advocacy Contact: Catherine Creme Henry, (202) 258-8228Investor Contacts: Loren Kalm, (650) 225-3217 Bruno Eschli, 011 41 61 687 5284 KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS ONCOLOGY SOURCE: Genentech Copyright Business Wire 2024. PUB: 12/08/2024 12:30 PM/DISC: 12/08/2024 12:30 PM http://www.businesswire.com/news/home/20241208818007/enSharing is not always caring: 7 dangerous things to post online
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Apple iOS 18 Hearing Aids: Are AirPods Pro 2 Headsets Sufficient Alternatives?PDP, led by Tiong (fourth right), in a group photo with new party comrades – Wong (third left), Rayong (right) and Baru (second right) – during the DUN Sarawak sitting in May 2024. ON April 6 at a hotel in Sibu, Bawang Assan assemblyman Dato Sri Wong Soon Koh and other leaders of the now-defunct Parti Sarawak Bersatu (PSB) officially joined a Gabungan Parti Sarawak (GPS) component, Progressive Democratic Party (PDP). With the inclusion of Wong, Engkilili assemblyman Dr Johnical Rayong and Ba Kelalan assemblyman Baru Bian, PDP now has a strength of eight assemblymen within the party. Wong, formerly PSB president, was appointed as PDP new senior vice-president, while Rayong and Baru were appointed as vice-presidents in their new party. Their admission into PDP came nine months after a memorandum of understanding (MoU) was signed in Kuala Lumpur for both sides to collaborate. Wong had, during the PDP Unity Dinner on April 6, said that PSB as an opposition party “has now become history.” He revealed that the approval letter for the party’s dissolution was received from the Registrar of Societies (RoS) on March 19. He also had said former PSB members were “happy to have chosen a new home, and happy with the decision to (join) PDP.” “Judging from the political situation in our country, we need strong governments at both the federal and state levels. “We therefore have decided to support the federal Madani Government under Prime Minister Datuk Seri Anwar Ibrahim, and the ‘People’s First’ state government under Premier Datuk Patinggi Tan Sri Abang Johari Tun Openg,” Wong said at the time. PDP president Datuk Seri Tiong King Sing had said that the entry of the leaders and members of now-dissolved PSB into PDP heralded “a new chapter of shared goals and stronger Sarawakian brotherhood.” He also thanked GPS leaders for their blessings and invaluable support of the PDP-PSB alliance. However, not everyone in GPS seemed too happy with this development. Clashes over two state seats, namely Bawang Assan and Engkilili, can be expected as these are the traditional seats contested by Sarawak United People’s Party (SUPP), the state’s oldest political party and another component of GPS. Abang Johari, also GPS chairman, had said that the matter on which party got to contest would be discussed “when the election is approaching.” Nevertheless, the admission of these three former PSB members to PDP has enabled them to officiate at government events and hand over government grants to recipients in their respective constituencies. Meanwhile, Batu Lintang assemblyman See Chee How, who became independent after quitting PSB in 2022, has been closely linked with SUPP, having been seen attending events with SUPP leaders. The speculation became intense after See was seen joining SUPP legislators in a meeting with Abang Johari at the State Legislative Assembly Complex in November. SUPP president, Deputy Premier Datuk Amar Dr Sim Kui Hian, has however brushed off rumours that See might soon join the party, since no application has been received. Batu Lintang is a traditional seat contested by SUPP. It was first won by See in 2016 on a Parti Keadilan Rakyat (PKR) ticket, and he successfully defended the seat for two more terms, including in 2021 as a PSB candidate. The presence of See (standing, third left) with SUPP leaders, seen here during a meeting with Abang Johari (seated centre) at the State Legislative Assembly Complex in November, has fuelled talks that he may soon join the party. Another seat clash with PDP is expected for Batu Lintang following Wong’s remarks about the party eyeing to reclaim the seat since PSB had invested significant resources and efforts to secure it in 2021. Wong also said that historically, Batu Lintang has not been a stronghold for SUPP. Meanwhile, GPS lynchpin Parti Pesaka Bumiputera Bersatu (PBB) will hold its 16th General Assembly in late January or early February next year. As such, all the 82 PBB branches have been holding their respective general meetings to elect their respective branch leaders, and to come up with resolutions for presentation at the PBB Convention. All those branches that have held their meetings so far, have come up with the same resolution for Abang Johari to be retained unopposed as PBB president in order to continue as GPS president and Premier of Sarawak. Meanwhile, Democratic Action Party (DAP) Sarawak has continued with its stance of being the opposition at the state level, despite working together with GPS in the Unity Government headed by PM Anwar. DAP Sarawak chairman Chong Chieng Jen, as Padungan assemblyman, is only one of two DAP state elected representatives in Sarawak – the other being Pending assemblywoman Violet Yong. Chong, also Stampin MP, had stated his view that GPS having command of 80 out of the 82 state seats was “not good for democracy in Sarawak, and surely is not in the interest of the common people of Sarawak.” Elsewhere, Parti Tenaga Rakyat Sarawak (Teras) is aiming for inclusion in Barisan Nasional (BN) following its rebranding. There is currently no BN component party in Sarawak, after the four components formerly under BN Sarawak left the coalition after the 2018 general election to form GPS.When building your watch list, look for stocks with an 80 or higher . ( ) stock just met that criteria with a new score of 80. Earlier this month, the semiconductor testing solutions company announced it received its first AI customer order for multiple high-power FOX-XP wafer level test and burn-in systems, in a deal valued at $10 million. This exclusive rating from Investor's Business Daily tracks market leadership with a 1 (worst) to 99 (best) score. The rating shows how a stock's price movement over the trailing 52 weeks holds up against all the other stocks in our database. Over 100 years of market history reveals that the stocks that go on to make the biggest gains often have an 80 or higher RS Rating as they launch their biggest climbs. Is Aehr Test Systems Stock A Buy? Aehr Test Systems stock reclaimed its 50- and 200-day moving averages mid-December and has been rallying since the announcement of AI deal. While now is not an ideal time to invest, see if the chip stock goes on to form a chart pattern and break out. The semiconductor testing solutions company posted negative growth for both the top and bottom lines last quarter. Aehr Test Systems is expected to report its next quarterly numbers on or around Jan. 9. Aehr Test Systems stock earns the No. 4 rank among its peers in the Electronics-Semiconductor Equipment industry group. ( ) is the top-ranked stock within the group.
Liverpool head coach Arne Slot continued to play down the significance of their place at the top of the Premier League despite it being strengthened by their 3-1 win over Leicester. Chelsea’s surprise defeat by Fulham meant victory over the Foxes stretched their lead to seven points, with a match in hand, with the halfway point of the campaign fast approaching. But Slot is maintaining his level-headed approach despite the clamour growing around their chances of adding another title to the one won in 2020. Tonight's goalscorers 💪 pic.twitter.com/xn9sfZbVow — Liverpool FC (@LFC) December 26, 2024 “If you are in this game for a long time like the players and I am then 20 games before the end you don’t look at it as there are so many challenges ahead of you,” he said after Cody Gakpo, Curtis Jones and Mohamed Salah scored to turn around an early deficit following Jordan Ayew’s strike. “Injuries and and a bit of bad luck can happen to any team, it is far too early to be already celebrating – but it is nice for us to be where we are. “I don’t think there was any easy win for us in any of these games; it could have been an easy win against Tottenham but we conceded two and it was then 5-2 – that tells you how difficult it is to win even when you have all your players available. “That is why we have to take it one game at a time. The league table is something of course we are aware of but we always understand how many games there are to go.” Leicester boss Ruud van Nistelrooy felt his side held their own until Salah scored in the 82nd minute. “I think we were in the contest for a result for a long time,” he said. “Three-one was the turning point in the sense the game was done there to get a result. “I think the 60th minute I remember a chanced for Daka to score the equaliser so we were in the game to get a surprising result. “We did well, we did what we could: a good start with the goal but if you speak of a turning point, 3-1 with Salah, the game was done.” Van Nistelrooy left goalkeeper Danny Ward out of the squad after he struggled in the defeat to Wolves and was jeered by his own fans. “The change in goal was one to make and the conversation with Wardy was impressive, the way he was thinking of the team and the club,” added the Dutchman. “I insisted on a conversation and of course it is a private conversation but what I want to share is the person and the professional he is. “I was impressed with that and his willingness for the team and the club to do well. “Really tough what happened for him. We are professionals but human beings as well, when frustration is being directed towards one person that is difficult.”